Metaxalone
- Product NDC
- 68788-8678
- 11-digit product format
- 687888678
- Labeler code
- 68788
- Product ID
- 68788-8678_2d64fbd7-ed7a-41e8-ad48-871385d86c5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2024-05-28
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metaxalone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METAXALONE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 351254 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8678-1 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 68788-8678-9 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8678 | METAXALONE TABLET [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20241114_8aa84e64-0075-4f22-a576-da085f32d56c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8678-1 | 68788867801 | 100 TABLET in 1 BOTTLE (68788-8678-1) | 100 tablet | 2024-05-28 | No | No | Historical |
| 68788-8678-9 | 68788867809 | 90 TABLET in 1 BOTTLE (68788-8678-9) | 90 tablet | 2024-05-28 | No | No | Historical |